Nickolas Coy
Kent,WA
Summary
Versatile Biotech Manufacturing Associate with a robust background in aseptic and benchtop operations. Proven expertise in Aseptic Process Simulations, validation processes, cross-departmental collaboration, and reviewing exceptions in electronic batch records. Seeking a challenging role to apply my skills in a dynamic biotech setting.
Overview
11
11
years of professional experience
Work History
Manufacturing Associate II
Lyell Immunopharma
Bothell, WA
05.2022 - Current
- Executed aseptic and non-aseptic operations in Cell Therapy, including Human PBMC, and Lenti Viral Vector (LVV) production, ensuring adherence to standard operating procedures (SOPs), and regulatory guidelines.
- At times, served, and excelled in an interim supervisor Lead.
- Led and facilitated regular meetings for the electronic batch record team to streamline lot disposition processes for Quality Assurance (QA).
- Led and facilitated regular meetings for the 5S Team to monitor and evaluate the effectiveness of 5S implementation, identifying areas for improvement.
- Collaborated with the validation department in drafting and executing smoke studies to ensure our procedures are FDA compliant.
- Collaborated cross-departmentally with QA, QC, and MSAT teams to streamline processes, resolve issues, and enhance overall efficiency.
- Collaborated with QA to review and address exceptions in electronic batch records (eBR), facilitating the streamlined dispositioning of patient lots.
- Created and revised SOPs and OJT materials, ensuring operational consistency and facilitating the onboarding process.
- Initiated, investigated, and took ownership of deviations, utilizing root cause analysis for effective corrective actions.
- Successfully trained over 30+ individuals, ensuring proficiency in manufacturing operations and strict adherence to aseptic techniques.
- Co-led the establishment, and facilitation of the training department, designing and implementing training programs for manufacturing operations and aseptic technique.
Lead Airplane Deicer
Integrated Deicing Services
SeaTac, WA
10.2017 - 04.2022
- Performed inspections on the aircraft to ensure they are within safety regulations for take-off, supervised the deicing of the aircraft.
- Conducted comprehensive reviews of all aircraft preventative maintenance documentation, ensuring strict adherence to FAA standards and regulations.
- Briefed and debriefed pilots and crew members performing functional check flights.
- Trained 40+ new employees on company policies and protocols.
- Performed pre-flight inspections on deicing truck, fluid supply system, and other related equipment.
- Provided assistance to pilots by communicating pertinent information about aircraft deicing procedures.
- Conducted daily safety meetings with crew members to review operational procedures and safety protocols.
- Followed strict protocol regarding the handling and disposal of hazardous materials used in deicing operations.
- Reviewed all documents pertaining
Laboratory Technician
TestAmerica/Eurofins
Tacoma, WA
04.2018 - 01.2019
- Processed specimens following established protocols while adhering to strict safety standards.
- Prepared solutions of reagents for use in experiments according to standard procedures.
- Assisted with training new lab technicians on proper operation of instruments, safety protocols, and other relevant topics.
- Collected, labeled and stored lab samples according to laboratory specifications.
- Adhered to Good Laboratory Practices (GLP) in all areas of responsibility.
Team Lead/Sergeant
United States Marine Corps
08.2013 - 08.2017
- Supervised, and managed a team of 13 personnel, overseeing daily and operational responsibilities.
- Provided leadership and guidance to team members, ensuring that tasks were completed on time and to a high standard.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Facilitated multiple small level training operations.
Education
Bachelor of Arts - Biochemistry
University of Washington
Seattle, WA12.2021
Skills
- Aseptic and benchtop operations
- Lenti Viral Vector (LVV) manufacturing
- Aseptic Process Simulations
- Smoke studies and validation processes
- Self-motivation and ability to learn quickly
- Strong work ethic in changing, diverse environments
- Cross-departmental collaboration (QA, QC, MSAT, PD)
- Strong understanding of cGMP regulations and regulatory requirement
- SOP and OJT development
- Process Improvement
- Deviation initiation, investigation, and ownership
- Training and mentoring
- Electronic Batch Record (EBR) review
- Meeting Facilitation
- Troubleshooting and problem-solving
- Excellent communication and interpersonal skills
- Werum PAS-X (MES)
- Oracle (ERP)
- Blue Mountain Regulatory Asset Manager (BMRAM)
Awards
- Alaska Air Group - Safety Operator Award Recognition 2019 (Individual)
- Integrated Deicing Services - Carl Thompson Safety Award 2019 (Individual)
Timeline
Manufacturing Associate II
Lyell Immunopharma
05.2022 - Current
Laboratory Technician
TestAmerica/Eurofins
04.2018 - 01.2019
Lead Airplane Deicer
Integrated Deicing Services
10.2017 - 04.2022
Team Lead/Sergeant
United States Marine Corps
08.2013 - 08.2017
Bachelor of Arts - Biochemistry
University of Washington
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